NCT01491386已完成不适用
A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
Medtronic Spinal and Biologics0 个研究点目标入组 279 人开始时间: 1998年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 279
- 主要终点
- Overall success
研究概览
简要总结
This study is designed to assess the safety and effectiveness of the rhBMP-2/ACS/LT-CAGE® device as compared to the LT-CAGE® device with autogenous bone in patients with symptomatic degenerative disc disease using an open surgical technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history ( e.g.,pain [leg, back, or symptoms in the sciatic nerve distribution], function deficit and/or neurological deficit) and radiographic studies ( e.g., CT, MRl, X-Ray, etc.) to include one or more of the following:
- •instability (defined as angular motion > 5° and/or translation >= 4mm, based on Flex/Ext radiographs);
- •osteophyte formation;
- •decreased disc height;
- •thickening of ligamentous tissue;
- •disc degeneration or herniation; and/or
- •facet joint degeneration.
- •Has preoperative Oswestry score >
- •Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.).
- •Has single-level symptomatic degenerative involvement from L4 to S
- •Is at least 18 years of age, inclusive, at the time of surgery.
- •Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of at least 6 months.
- •If female of child-bearing potential, who is not pregnant or nursing, and who agrees to use adequate contraception for 16 weeks following surgery.
- •Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.
排除标准
- •Had previous anterior spinal fusion surgical procedure at the involved level.
- •Has posterior spinal instrumentation (which will not be removed) stabilizing the involved level or has had a previous posterior lumbar interbody fusion procedure at the involved level.
- •Has a condition which requires postoperative medications that interfere with fusion, such as steroids.
- •Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
- •Has presence of active malignancy.
- •Has overt or active bacterial infection, either local or systemic.
- •ls grossly obese, i.e., weight > 40% over ideal for their age and height.
- •Has fever ( temperature > 101° F oral) at the time of surgery.
- •Has a documented titanium alloy allergy or intolerance.
- •Is mentally incompetent. if questionable, obtain psychiatric consult.
- •Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
- •Is a prisoner.
- •Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug usage.
- •Is a tobacco user at the time of surgery.
- •Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids or methotrexate).
- •Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
- •Has a history of exposure to injectable collagen implants.
- •Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
- •Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/ACS implantation.
- •Has received any previous exposure to any/all BMP's of either human or animal extraction.
- •Has a history of allergy to bovine products or a history of anaphylaxis.
- •Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers- Danlos syndrome, or osteogenesis imperfecta).
结局指标
主要结局
Overall success
时间窗: 24 months
A patient will be considered an overall success if all of the following conditions are met: 1. fusion; 2. pain/disability (Oswestry) improvement; 3. maintenance or improvement in neurological status; 4. no serious adverse event classified as implant associated or implant/surgical procedure associated; 5. no additional surgical procedure classified as a "failure."
次要结局
- General Health Status (SF-36)(24 months)
- Pain Status (Numerical Rating Scale)(24 months)
- Disc Height Measurement(24 months)
- Patient Satisfaction(24 months)
- Patient Global Perceived Effect(24 months)
研究者
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